Cited by 723Respiratory Support and MechanismsSepsis Diagnosis and TreatmentNosocomial Infections in ICU

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Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial

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Girardis, Massimo, Busani, Stefano, Damiani, Elisa, Donati, Abele, Rinaldi, Laura, Marudi, Andrea, Morelli, Andrea, Antonelli, Massimo, Singer, Mervyn·2016·JAMA

DOI 10.1001/jama.2016.11993

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Abstract

Importance: Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. Objective: To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). Design, Setting, and Patients: Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. Interventions: Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). Main Outcomes and Measures: The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. Results: A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0.57 [95% CI, 0.37-0.90]; P = .01). Occurrences were lower in the conservative oxygen therapy group for new shock episode (ARR, 0.068 [95% CI, 0.020-0.120]; RR, 0.35 [95% CI, 0.16-0.75]; P = .006) or liver failure (ARR, 0.046 [95% CI, 0.008-0.088]; RR, 0.29 [95% CI, 0.10-0.82]; P = .02) and new bloodstream infection (ARR, 0.05 [95% CI, 0.00-0.09]; RR, 0.50 [95% CI, 0.25-0.998; P = .049). Conclusions and Relevance: Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy vs conventional therapy resulted in lower ICU mortality. These preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of this approach. Trial Registration: clinicaltrials.gov Identifier: NCT01319643.

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Additional file 1 of The ability of Oxygen Reserve Index® to detect hyperoxia in critically ill patients
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Additional file 3 of A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
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Additional file 2 of Early hyperoxemia is associated with lower adjusted mortality after severe trauma: results from a French registry
Bækgaard, J. S., Abback, P.-S., Boubaya, M., Moyer, J.-D., Garrigue, D., Raux, M., Champigneulle, B., Dubreuil, G., Pottecher, J., Laitselart, P., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13082930
Additional file 2 of ARDS Clinical Practice Guideline 2021
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Additional file 1 of Trajectories of hypoxemia and pulmonary mechanics of COVID-19 ARDS in the NorthCARDS dataset
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Additional file 1 of Conservative versus liberal oxygen therapy for intensive care unit patients: meta-analysis of randomized controlled trials
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Additional file 2 of Time-varying intensity of oxygen exposure is associated with mortality in critically ill patients with mechanical ventilation
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Additional file 1 of Time-varying intensity of oxygen exposure is associated with mortality in critically ill patients with mechanical ventilation
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Additional file 4 of ARDS Clinical Practice Guideline 2021
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Additional file 1 of Hyperoxemia during resuscitation of trauma patients and increased intensive care unit length of stay: inverse probability of treatment weighting analysis
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Additional file 4 of Effect of low-to-moderate hyperoxia on lung injury in preclinical animal models: a systematic review and meta-analysis
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Additional file 2 of Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials
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Additional file 3 of Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials
Chen, X.-L., Zhang, B.-L., Meng, C., Huang, H.-B., & Du, B. (2021) · Figshare · doi:10.6084/m9.figshare.15040813
Additional file 1 of Early hyperoxemia is associated with lower adjusted mortality after severe trauma: results from a French registry
Bækgaard, J. S., Abback, P.-S., Boubaya, M., Moyer, J.-D., Garrigue, D., Raux, M., Champigneulle, B., Dubreuil, G., Pottecher, J., Laitselart, P., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13082927
Additional file 3 of Effect of low-to-moderate hyperoxia on lung injury in preclinical animal models: a systematic review and meta-analysis
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Additional file 1 of Hyperoxaemia and hypoxaemia are associated with harm in patients with ARDS
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Additional file 2 of The ability of Oxygen Reserve Index® to detect hyperoxia in critically ill patients
de Courson, H., Julien-Laferrière, T., Georges, D., Boyer, P., Verchère, E., & Biais, M. (2022) · Figshare · doi:10.6084/m9.figshare.19778242
Additional file 3 of Early hyperoxemia is associated with lower adjusted mortality after severe trauma: results from a French registry
Bækgaard, J. S., Abback, P.-S., Boubaya, M., Moyer, J.-D., Garrigue, D., Raux, M., Champigneulle, B., Dubreuil, G., Pottecher, J., Laitselart, P., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13082933
Additional file 1 of Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials
Chen, X.-L., Zhang, B.-L., Meng, C., Huang, H.-B., & Du, B. (2021) · Figshare · doi:10.6084/m9.figshare.15040807
Additional file 1 of Effect of low-to-moderate hyperoxia on lung injury in preclinical animal models: a systematic review and meta-analysis
Minkove, S. J., Dhamapurkar, R., Cui, X., Li, Y., Sun, J., Cooper, D., Eichacker, P. Q., & Torabi‐Parizi, P. (2023) · Figshare · doi:10.6084/m9.figshare.22681113
Additional file 3 of Hyperoxia for accidental hypothermia and increased mortality: a post-hoc analysis of a multicenter prospective observational study
Yamamoto, R., Yoshizawa, J., Takauji, S., Hayakawa, M., & Sasaki, J. (2024) · Figshare · doi:10.6084/m9.figshare.26579774
Additional file 1 of Transparent decision support for mechanical ventilation using visualization of clinical preferences
Rees, S. E., Spadaro, S., Corte, F. D., Dey, N., Brohus, J. B., Scaramuzzo, G., Lodahl, D., Winding, R., Volta, C. A., & Karbing, D. S. (2022) · Figshare · doi:10.6084/m9.figshare.19029306
Additional file 2 of A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
Dylla, L., Douin, D. J., Anderson, E. L., Rice, J. D., Jackson, C. L., Bebarta, V. S., Lindsell, C. J., Cheng, A., Schauer, S. G., & Ginde, A. A. (2021) · Figshare · doi:10.6084/m9.figshare.16960240
Additional file 4 of Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials
Chen, X.-L., Zhang, B.-L., Meng, C., Huang, H.-B., & Du, B. (2021) · Figshare · doi:10.6084/m9.figshare.15040816
Additional file 3 of ARDS Clinical Practice Guideline 2021
Tasaka, S., Ohshimo, S., Takeuchi, M., Yasuda, H., Ichikado, K., Tsushima, K., Egi, M., Hashimoto, S., Shime, N., Saito, O., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20267849
Additional file 5 of Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials
Chen, X.-L., Zhang, B.-L., Meng, C., Huang, H.-B., & Du, B. (2021) · Figshare · doi:10.6084/m9.figshare.15040819
Additional file 1 of The association of arterial partial oxygen pressure with mortality in critically ill sepsis patients: a nationwide observational cohort study
Hyun, D.-G., Ahn, J. H., Huh, J. W., Hong, S.-B., Koh, Y., Oh, D. K., Lee, S. Y., Park, M. H., & 임채만 (2024) · Figshare · doi:10.6084/m9.figshare.25939960
Additional file 6 of ARDS Clinical Practice Guideline 2021
Tasaka, S., Ohshimo, S., Takeuchi, M., Yasuda, H., Ichikado, K., Tsushima, K., Egi, M., Hashimoto, S., Shime, N., Saito, O., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20267858
Additional file 1 of ARDS Clinical Practice Guideline 2021
Tasaka, S., Ohshimo, S., Takeuchi, M., Yasuda, H., Ichikado, K., Kenji, T., Egi, M., Hashimoto, S., Shime, N., Saito, O., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20267840
Additional file 1 of Positive single-center randomized trials and subsequent multicenter randomized trials in critically ill patients: a systematic review
Kotani, Y., Turi, S., Ortalda, A., Baiardo Redaelli, M., Marchetti, C., Landoni, G., & Bellomo, R. (2024) · Figshare · doi:10.6084/m9.figshare.26646508
Additional file 1 of Effects of intraoperative inspired oxygen fraction (FiO2 0.3 vs 0.8) on patients undergoing off-pump coronary artery bypass grafting: the CARROT multicenter, cluster-randomized trial
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Additional file 6 of Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials
Chen, X.-L., Zhang, B.-L., Meng, C., Huang, H.-B., & Du, B. (2021) · Figshare · doi:10.6084/m9.figshare.15040822
Additional file 2 of Effect of low-to-moderate hyperoxia on lung injury in preclinical animal models: a systematic review and meta-analysis
Minkove, S. J., Dhamapurkar, R., Cui, X., Li, Y., Sun, J., Cooper, D., Eichacker, P. Q., & Torabi‐Parizi, P. (2023) · Figshare · doi:10.6084/m9.figshare.22681116
Additional file 2 of Hyperoxia for accidental hypothermia and increased mortality: a post-hoc analysis of a multicenter prospective observational study
Yamamoto, R., Yoshizawa, J., Takauji, S., Hayakawa, M., & Sasaki, J. (2024) · Figshare · doi:10.6084/m9.figshare.26579771
Additional file 1 of Hyperoxia for accidental hypothermia and increased mortality: a post-hoc analysis of a multicenter prospective observational study
Yamamoto, R., Yoshizawa, J., Takauji, S., Hayakawa, M., & Sasaki, J. (2024) · Figshare · doi:10.6084/m9.figshare.26579768
Additional file 3 of The ability of Oxygen Reserve Index® to detect hyperoxia in critically ill patients
de Courson, H., Julien-Laferrière, T., Georges, D., Boyer, P., Verchère, E., & Biais, M. (2022) · Figshare · doi:10.6084/m9.figshare.19778245
Additional file 5 of ARDS Clinical Practice Guideline 2021
Tasaka, S., Ohshimo, S., Takeuchi, M., Hideto, Y., Ichikado, K., Tsushima, K., Egi, M., Hashimoto, S., Shime, N., Saito, O., et al. (2022) · Figshare · doi:10.6084/m9.figshare.20267855
Additional file 1 of A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
Dylla, L., Douin, D. J., Anderson, E. L., Rice, J. D., Jackson, C. L., Bebarta, V. S., Lindsell, C. J., Cheng, A., Schauer, S. G., & Ginde, A. A. (2021) · Figshare · doi:10.6084/m9.figshare.16960237
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Authors: Girardis, M., Busani, S., Damiani, E., Donati, A., Rinaldi, L., Marudi, A., Morelli, A., Antonelli, M., & Singer, M.
Affiliations: Azienda Ospedaliero-Universitaria di Modena (IT)
Marche Polytechnic University (IT)
Intensive Care Unit, Department of Anaesthesiology and Intensive Care, NOCSAE Hospital, Modena, Italy
Sapienza University of Rome (IT)
Università Cattolica del Sacro Cuore (IT)
University College London (GB)
Corresponding author: Girardis, Massimo
ORCID: Girardis, Massimo
Busani, Stefano
Damiani, Elisa
Donati, Abele
Morelli, Andrea
Antonelli, Massimo
Singer, Mervyn
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2016-10-18
Volume: 316
Issue: 15
Pages: 1583
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.2016.11993
OpenAlex: W2528556615
Cited by: 723
References: 35
Citations by year: 2026: 34 · 2025: 58 · 2024: 61 · 2023: 66 · 2022: 89 · 2021: 105 · 2020: 97 · 2019: 59 · 2018: 73 · 2017: 75 · 2016: 4
FWCI: 63.04
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
UCL Discovery (University College London) (submittedVersion)
Università Politecnica delle Marche (Università Politecnica delle Marche) (submittedVersion)
Funders: Università Degli Studi di Modena e Reggio Emila
InflaRx
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Sepsis Diagnosis and Treatment
Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Nosocomial Infections in ICU
Keywords: conservative oxygen therapy, hyperoxemia, arterial oxygenation, ICU mortality, critically ill patients, supplemental oxygen, arterial oxygen partial pressure, oxygen saturation, organ failure, infection, mechanical ventilation, intensive care unit admission criteria
MeSH terms: Adult, Aged, Cross Infection, Female, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Oxygen, Oxygen Inhalation Therapy, Partial Pressure, Shock, Critical Illness, Hospital Mortality, Liver Failure, Hyperoxia, Early Termination of Clinical Trials

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Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial

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